Effectiveness of Dry Needling and Physical Therapy Versus Physical Therapy Alone Following Shoulder Stabilization Repair

Shoulder Pain Clinical Trial

Official title:

Effectiveness of Trigger Point Dry Needling and Physical Therapy Versus Physical Therapy Alone Following Shoulder Stabilization Repair: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02704975
• Other study ID #: 16-007
• Status: Completed
• Phase: N/A
• First received: March 1, 2016
• Last updated: March 5, 2018
• Start date: March 2016
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: Keller Army Community Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this single-blinded, randomized clinical trial is to determine the effectiveness of dry needling compared to a standard shoulder rehabilitation program on range of motion, functional movement, and pain in patients who have undergone shoulder stabilization surgery. Measurements of the aforementioned dependent variables will be taken at time intervals of four weeks, eight weeks, 12 weeks, and six months post-operatively. It is hypothesized that the inclusion of dry needling will result in an increase in range of motion, increase in functional movement, and decrease in pain at an accelerated rate when compared to rehabilitation alone.

Description:

Methodology /Technical Approach 30-50 subjects at least four weeks after shoulder stabilization surgery will be randomized into two groups (one experimental group and one control group). Subjects in the experimental group will receive Trigger Point Dry Needling (TDN) intervention with standard rehabilitation protocol (Appendix A) while subjects in the control group will receive the same standard rehabilitation protocol without TDN. The experimental group will receive trigger point dry needling one time per week for four to six weeks in addition to the standard rehabilitation protocol. The control group will receive only the standard rehabilitation protocol. Baseline measurements will be taken at approximately four weeks post operatively, and subsequent measurements will be recorded at eight weeks, 12 weeks, and six months.

All patients who have undergone a shoulder stabilization procedure will be invited to participate. Description of the study and informed consent will take place prior to randomization. Concealed randomization will take place 0-7 days post-operatively.

At 4 weeks post-operatively, the following assessment tests will be undertaken: supine shoulder flexion, supine shoulder external rotation, supine shoulder internal rotation, functional movement testing, functional outcome measures, and the numeric pain rating scale. 1,2,3 Those subjects in the 'experimental group' will receive manual palpation of all upper quarter muscles, including the cervical and thoracic spine region, to detect the presence of myofascial trigger points (TPs). Dry needling will be performed to all detected TPs by a provider trained and experienced in TDN.

In addition to the TDN intervention, the experimental group subjects will undergo a rehabilitation program in accordance with a shoulder stabilization repair protocol which is the standard of care for this surgical procedure. Per the shoulder stabilization protocol, subjects will be instructed in a home exercise plan (HEP) that will reinforce the clinical treatment, will be provided with a handout of instructions, and will be required to demonstrate all exercises correctly.

Subjects in the 'control group' will undergo a rehabilitation program as described above for the 'experimental group', except that they will not receive a TDN intervention.

Objectives:

1. To determine if the addition of upper quarter TDN to a rehabilitation protocol is more effective in improving range of motion and functional movement when compared to a rehabilitation protocol alone after shoulder stabilization surgery.

2. To determine if the addition of upper quarter TDN to a rehabilitation protocol is more effective in decreasing pain than a rehabilitation protocol alone after shoulder stabilization surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 18-40 yo DOD Beneficiaries

• Status Post Shoulder Stabilization Repair Surgery

Exclusion Criteria:

• Self-Reported Pregnancy

• History of blood borne pathogens/infectious disease/active infection/metal allergy

• Bleeding disorders or currently taking anti-coagulant medications

• Participants who are not fluent in English

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Device:
• Rehabilitation and Dry Needling
Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months. Subjects in this group will also receive dry needling as an adjunct intervention. Dry needling treatment will be performed one time a week for four weeks and will begin four weeks post-operative.
• Rehabilitation
Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Keller Army Community Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Flexion and External Rotation Passive Range of Motion as measured with standard Goniometer	Baseline ROM change from baseline 4 week time point to follow up at 8 week time point	Change from Baseline at 4 weeks to 8 weeks
Secondary	Global Rating of Change Score		4 weeks, 8 weeks, 12 weeks, 6 months
Secondary	Patient Specific Functional Score		4 weeks, 8 weeks, 12 weeks, 6 months
Secondary	Shoulder Pain and Disability Index		4 weeks, 8 weeks, 12 weeks, 6 months
Secondary	Shoulder Functional Movement		4 weeks, 8 weeks, 12 weeks, 6 months
Secondary	Pain	Numeric Pain Rating Scale	4 weeks, 8 weeks, 12 weeks, 6 months
Secondary	Shoulder Flexion and External Rotation Passive Range of Motion as measured with standard Goniometer		12 weeks, 6 months